Infertility Clinical Trial
Official title:
Calcium Dobesilate Versus Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome
Verified date | February 2017 |
Source | Benha University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to compare the effect of oral Calcium Dobesilate to oral Cabergoline in the prevention of ovarian hyperstimulation syndrome (OHSS) in high-risk women underwent intracytoplasmic sperm injection (ICSI).
Status | Completed |
Enrollment | 200 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 22 Years to 44 Years |
Eligibility |
Patients enrolled in the study were infertile women undergoing ICSI with one of the
following criteria: previous episodes of OHSS, polycystic ovaries (i.e., > 24 antral
follicles present on baseline ultrasound examination), high AMH (> 3.0 ng/mL), large
number of small follicles (8 to 12 mm) seen on ultrasound during ovarian stimulation, high
s.E2 at hCG trigger (E2 >3000 pg/ml or rapidly rising s.E2), presence of > 20 follicles by
ultrasound on day of retrieval or large number of oocytes retrieved (> 20). Exclusion Criteria: |
Country | Name | City | State |
---|---|---|---|
Egypt | Benha univesity hospital | Benha | El Qualyobia |
Lead Sponsor | Collaborator |
---|---|
Benha University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with ovarian hyperstimulation syndrome (OHSS) | this will be assessed by: Clinically: Abdominal bloating Mild abdominal pain Nausea ± vomiting Oliguria Acute respiratory distress syndrome By ultrasound Ovarian size usually ?8 cm Ultrasound evidence of ascites Laboratory Haemoconcentration haematocrit ?45% Hypoproteinaemia |
weekly for eight weeks | |
Secondary | pregnancy rate | ß-hCG (serum hCG test) will be checked 14 days after embryos transfer | 14 days after embryos transfer |
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